Actively Recruiting
Phase 1 Study of NILK-2301 Antibody Treatment for Adults with Locally Advanced or Metastatic Low Tumor Volume Colorectal Cancer
Led by Light Chain Bioscience - Novimmune SA · Updated on 2024-10-29
25
Participants Needed
2
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying NILK-2301, a bispecific antibody, in patients with locally advanced or metastatic low tumor volume colorectal cancer. This open-label, Phase 1 clinical trial aims to find the safest dose and evaluate the effects of NILK-2301 administered alone. The study includes two parts dose escalation to determine the maximum tolerated dose and expansion to assess safety and efficacy at or below this dose. Participants will receive NILK-2301 treatments every two weeks in 28-day cycles for up to 12 months. Treatment may continue beyond one year if ongoing benefit is observed. The study will monitor patients during dose escalation and expansion phases to assess safety, tolerability, and response. During the trial, participants will undergo regular safety assessments including monitoring for dose limiting toxicities, adverse events, and laboratory tests. Researchers will also evaluate progression-free survival, overall survival, drug levels in the body, and the presence of anti-drug antibodies. Participation can last up to 12 months, with treatment continuing until disease progression, unacceptable side effects, or withdrawal by participant or investigator.
CONDITIONS
Brief Title
A Study of NILK-2301 in Patients with Locally Advanced or Metastatic Low Tumor Volume (LTV) Colorectal Cancer
Research Team
C
Clinical Project Manager
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